BioCardia (NASDAQ:BCDA) news for Monday includes an announcement concerning interim clinical trial results boosting BCDA stock higher.
According to the BioCardia news release, the company is preparing to receive interim data from its Phase 3 CardiAMP Heart Failure Trial. This trial is testing the use of BCDA’s CardiAMP autologous cell therapy to the myocardium to treat patients with ischemic heart failure.
BioCardia notes that it is expecting data safety monitoring board (DSMB) verbal feedback by the end of tomorrow. Following this, it will get the written feedback within 24 hours. The company plans to release a summary of the interim results before the markets open on Thursday.
The BioCardia news release mentions that the Phase 3 trial has confirmation from the U.S. Food and Drug Administration (FDA) “as a pivotal trial to produce the primary data to support market registration for the CardiAMP cell therapy for this significant unmet clinical need.”
BioCardia is still enrolling patients in the Phase 3 CardiAMP Heart Failure Trial. The company is allowed up to 260 patients across a maximum of 40 centers. The results of this study will determine the safety and efficacy of using the treatment for ischemic heart failure.
BioCardia says it will be providing the next steps of its plans for CardiAMP in its press release on Thursday. If the interim results are positive, it may give BCDA stock investors an idea of what to expect from the company in the future.
BCDA stock was up 92.9% as of Monday afternoon.
On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article.
